Stepwise Process for Improving the Quality of HIV-related POCT Sites Towards Certification

Transcription

1 Implementing Quality-Assured Point-of-Care Testing Stepwise Process for Improving the Quality of HIV-related POCT Sites Towards Certification Center for Global Health Division of Global HIV and TB*- International Laboratory Branch

2 From Conventional Testing to POCT New Guidelines and Targets including ACT and UNAIDS 90/90/90 Gaps in Testing and Treatment Cascade POCT has been shown to reduce patient loss to follow-up and increase access to ART Increase the availability of testing by expanding coverage of testing beyond urban centres Expedited diagnosis with POCT reported to decrease disease transmission and improve health outcomes 2

3 Rapid Scale-up of POCT Rapid scale-up of POCT without simultaneous capacity building of quality assurance unreliable results Reports of high misdiagnosis rates of HIV using rapid diagnostic tests. False positive results - up to 10.5% of patients tested HIV negative patients incorrectly put on lifelong ART: enduring stress, stigma, and discrimination High rates of invalid tests of up to 14% using POC CD4 Widely accepted most POC CD4 testing errors -operator errors associated with specimen quality and handling 3

4 Preparing Testing Sites Towards Certification 4

5 SPI-POCT Checklist: A Closer Look SPI-POCT Checklist Sections Points 1. Integration of POCT Services for Patient Care 6 2. Personnel Training, Competency, and Certification Physical Facilities 5 4. Safety 6 5. Pre-Testing Phase 6 6. Testing Phase 5 7. Post-Testing Phase 5 8. Supplies, Reagents and Equipment Quality Monitoring 6 Total points

6 Certifying Testing Sites Through a Stepwise Process Level 4 Level 3 Level 2 Level 1 Level 0 >90% Eligible for national site certification 80% - 89% Close to national site certification 60% - 79% Partially ready for national site certification 40% - 59% needs improvement in specific areas <40% Need improvement in all areas and remediation 6

7 SPI-RT CHECKLIST WHAT CAN WE LEARN FROM THE RTQII S USE OF SPI-RT? 7

8 SPI-RT Roll out 2. Regional sensitization 1. MOH Endorsement 3. Training Regional implementers 4. Preparing for site visits 5. Conducting Site visits 6. Provide feedback to the site, corrective actions 8

9 Providing Corrective Actions Based on Assessment Findings SPI-RT Component Findings Corrective actions Safety No job aides to implement safety practice, dispose waste, and manage occupational exposure to body fluids Pre and Testing Phase No job aides (sample collection, HIV rapid kit procedures) No timer Procedure not followed No documentation of IQC No supervisor review Document and Records Kit names, lot numbers, expiration dates, individual HIV results are not captured EQA Testing points are not enrolled in PT program Provide job aides Provide job aides and timer Onsite training and supervision Introduce standardized HIV rapid testing logbook Enroll all HIV testing points in EQA program 9

10 Baseline Assessment Using SPI-RT Checklist-Country X (Partial data) Personnel Training & Certification 100 External Quality Assessment Physical Facility 40 Baseline 20 Q1 Document & Record 0 Safety Q2 Q3 Q4 Post-testing Phase Pre-testing phase Testing Phase

11 Baseline Assessment Using SPI-RT Checklist-Country X (Partial data) Level 0 (<40%) Level 1 (40-59%) Level 2 (60-79%) Level 3 (80-89%) Level 4 (>90%) Q4 Q3 Q2 Q1 Baseline Percent of sites assessed

12 Continuously Improving Quality at Site level Q4 Q3 Q2 Q1 Country A Q4 Q3 Q2 Q1 Country C Baseline Baseline Percent of sites assessed Percent of sites assessed 12

13 SPI-POCTCHECKLIST IMPLEMENTATION APPROACH 7

14 SPI-POCT Checklist Harmonize with International Regulations Standardized Sites are evaluated in consistent manner Data is comparable Comprehensive but not too laborious 9 sections, 57 questions Identify priorities at the site-level but also across districts or at the national level Track progress through continuous M & E

15 Implementing SPI-POCT towards Site Certification High Level Engagement Policy Development Work plan development Standards & targets set up Step-wise Roll-out Continuous M&E

16 Building Institutional Capacity and Local Partnership Establish a national certification program for POCT sites Engaging MOH to define certification process Developing policy Developing guidelines and implementation plan Setting certification standards Tools database Foster collaboration to increase uptake of QA measures Managing assessors Monitoring site performance using SPI checklist Training and certification Leverage local partners strengthen for sustainability

17 Thank you! For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA Telephone: CDC-INFO ( )/TTY: Visit: Contact CDC at: CDC-INFO or The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. Center for Global Health Division of Global HIV and TB* International Laboratory Branch